Critical Access Hospitals (CAH)
What every CAH needs to know about the
Conditions of Participation (CoPs)
Speaker
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
sdill1@columbus.rr.com
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You Don’t Want One of These
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Mandatory Compliance
Hospitals that participate in
Medicare or Medicaid must
meet the Conditions of
Participation (COPs) for all
patients in the facilities and not
just those who are Medicare or
Medicaid patients,
Hospitals accredited by the
Joint Commission (TJC), AOA,
CIHQ, or DNV Healthcare have
what is called deemed status,
4
CAH Problematic Standards
Date and time on all orders and entries
Verbal orders, Cluttered hallways
H&Ps, Life safety code issues, EMTALA,
Informed consent, Cleanliness of dietary
Plan of care, Privacy and whiteboard,
Handling, dispensing, storage and
administration of medications
Meeting the nutritional needs of patients
Healthcare services in accordance with P&P
5
CAH Problematic Standards
Medical record documentation must reflect
the nursing process, Timing of medications
Legibility of the medical record, No orders
Equipment and supplies used in life saving
procedure, Hand Hygiene & Gloving
R&S for PPS hospitals but CAH still need to
do something, Failure to Monitor Patient for
Safety (Suicide Precautions)
Infection control issues are big
What else should we add???
6
Access to Hospital Complaint Data
CMS issued Survey and Certification memo
on March 22, 2013 regarding access to
hospital complaint data
Includes acute care and CAH hospitals
 Does not include the plan of correction but can request
 Questions to bettercare@cms.hhs.com
This is the CMS 2567 deficiency data and
lists the tag numbers
Updating quarterly
 Available under downloads on the hospital website at www.cms.gov
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Access to Hospital Complaint Data
There is a list that includes the hospital’s
name and the different tag numbers that
were found to be out of compliance
 Many on restraints and seclusion, EMTALA,
infection control, patient rights including
consent, advance directives and grievances
Two websites by private entities also publish
the CMS nursing home survey data
 The ProPublica website for LTC
 The Association for Health Care Journalist (AHCJ)
websites for hospitals
8
Access to Hospital Complaint Data
9
Updated Deficiency Data Reports
www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc/Hospitals.html
10
Small or Rural Hospitals
American Hospital Association has Web
site with good information for CAH
Has recent issues of interest to CAH
Excellent resources including current list
of all CAHs in the US
Has CAH newsletters
 go to http://www.aha.org/aha/issues/RuralHealth-Care/update-newsletters.html
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AHA CAH Resources
www.aha.org/aha/issues/RuralHealth-Care/updatenewsletters.html
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AHA CAH Resources
www.aha.org/advocacyissues/rural/updatenewsletters.shtml
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CMS Updated Website www.cms.gov
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AHA Critical Access Website
www.aha.org/aha_app/issues/CAH/index.jsp
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Rural Assistance Center
www.raconline.org
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Rural Assistance Center
www.raconline.org
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CMS CAH Website
CMS has a website for resources
Includes:
 State operations manuals
 Program transmittals
 Guidance for laws and regulations for
CAH
 Medicare Learning network
 Other helpful information
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CMS CAH Website
ww.cms.gov/center/cah.asp
http://www.cms.gov/Center/ProviderType/Critical-Access-HospitalsCenter.html?redirect=/center/cah.asp
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Critical Access Hospitals
 Confusing when CMS says hospitals must do this but
will specifically mention CAH must do…
 Changes affecting CAH hospitals included Medicare
Discharge Appeal Rights, Visitation and the
Telemedicine
 Verbal order Tag Number 297,H&P 320,
 IV Medication and blood memo changed June 7, 2013

Informed consent 304 and 320,
 Security of Medications 276,
 Anesthesia assessments 321,
 Infection control 278 but you should still look at these!
 Privacy and confidentiality but you should look at these also!
20
The Conditions of Participation CoPs
First, published in the Federal Register
Federal Register available at no charge at
www.gpoaccess.gov/fr/index.html
Next, CMS publishes Interpretive Guidelines
and some include survey procedures,
Current CoP issued April 11, 2014
Changes to tag 162 and 226 on January 31, 2014
and April change from MR/DD to intellectual disability
CMS made many changes effective June 7,
2013
1 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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Subscribe to the Federal Register Free
http://listserv.access.gp
o.gov/cgibin/wa.exe?SUBED1=
FEDREGTOC-L&A=1
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new website at
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
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www.cms.gov/manuals/Downloads/som107ap_w_cah.pdf
and is critical access hospital CoPf
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CAH Manual 227 Pages
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CAH Services Direct Services or Contracts
CMS published more than 2 dozens changes
to the hospital CoP in FR on May 16, 2012
and went into effect June 7, 2013
Several that impact CAHs
Currently. The CAH CoP requires that certain
types of services be provided directly rather
than through contracts or under arrangements
 This included diagnostic and therapeutic
services, lab and radiology services, and
emergency procedures
 CMS eliminated this requirement
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CMS Changes July 11, 2014
CMS published some final changes to
hospital CoP on May 7, 2014 and effective
July 11, 2014
 www.ofr.gov/(S(5jsvvwmsi4nfjrynav20ebeq))/OFRUpload/OFRData/
2014-10687_PI.pdf
 Says will save healthcare providers $660 million annually and
3.2 billion over five years
Several are important to the CAHs
 CAH P&P committee deleted requirement for
non-staff member requirement
 Swing beds moved to Part D so accreditation
organizations can survey
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Final Federal Register Changes
www.ofr.gov/(S(5jsvvwmsi4nfjrynav20ebeq))/OFR
Upload/OFRData/2014-10687_PI.pdf
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How to Find Changes
Have one person in your facility who
goes out to this website once a month
and checks for updates,
 www.cms.hhs.gov/SurveyCertificationGenI
nfo/PMSR/list.asp,
You can do a search for time frame and
can add words to search,
 Click on fiscal year to bring up most current memos
CMS issues transmittal before putting it
into the CAH Manual
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CMS Survey and Certification Website
www.cms.gov/SurveyCertific
ationGenInfo/PMSR/list.asp#
TopOfPage
Click on Policy & Memo to
States
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31
CMS Transmittals
www.cms.gov/Transmittals/01_overview.asp
http
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Safe Opioid Use
CMS issues advance copy of survey memo
on medication administration and safe opioid
use dated March 14, 2014
CAH should be aware of this even though it
was written for non-CAH
Make sure staff are educated on how to
safely care for patients on opioids
Including how to monitor and document
compliance
Includes what to tell patients on opioids
33
Medication and Safe Opioid Use
www.cms.gov/SurveyCertificationG
enInfo/PMSR/list.asp#TopOfPage
34
CMS Memo on Safe Injection Practices
CMS issues a 7 page memo on safe injection
practices
Discusses the safe use of single dose
medication to prevent healthcare associated
infections (HAI)
Notes exception which is important especially
in medications shortages
 General rule is that single dose vial (SDV)can only be used
on one patient
 Will allow SDV to be used on multiple patients if prepared by
pharmacist under laminar hood following USP 797 guidelines
35
Safe Injection Practices
http://www.cms.gov/Medicare/ProviderEnrollment-andCertification/SurveyCertificationGenInfo/index.ht
ml?redirect=/SurveyCertificationGenInfo/PMSR/li
st.asp
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CMS Memo on Safe Injection Practices
 All entries into a SDV for purposes of repackaging
must be completed with 6 hours of the initial
puncture in pharmacy following USP guidelines
 Only exception of when SDV can be used on
multiple patients
 Otherwise using a single dose vial on multiple
patients is a violation of CDC standards
 CMS will cite hospital under the hospital CoP
infection control standards since must provide
sanitary environment
 Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.
37
CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial
on multiple patients
 CMS has section in IC worksheet on this
 CMS requires hospitals to follow nationally
recognized standards of care like the CDC
guidelines
 SDV typically lack an antimicrobial preservative
 Once the vial is entered the contents can support
the growth of microorganisms
 The vials must have a beyond use date (BUD)
and storage conditions on the label
38
CMS Memo on Safe Injection Practices
 Make sure pharmacist has a copy of this memo
 If medication is repackaged under an arrangement
with an off site vendor or compounding facility ask
for evidence they have adhered to 797 standards
 ASHP Foundation has a tool for assessing
contractors who provide sterile products
Go to
www.ashpfoundation.org/MainMenuCategories/Practic
eTools/SterileProductsTool.aspx
 Click on starting using sterile products outsourcing tool
now
39
Not All Vials Are Created Equal
40
CMS Memo on Insulin Pens
CMS issues memo on insulin pens
Insulin pens are intended to be used on one
patient only
 CMS notes that some healthcare providers are
not aware of this
 Insulin pens were used on more than one
patient which is like sharing needles
 Every patient must have their own insulin pen
 Insulin pens must be marked with the patient’s
name
41
CMS Memo on Insulin Pens
Regurgitation of blood into the insulin
cartridge after injection can occur creating a
risk if used on more than one patient
Hospital needs to have a policy and
procedure
Staff should be educated regarding the safe
use of insulin pens
More than 2,000 patients were notified in
2011 because an insulin pen was used on
more than one patient
42
CDC issues reminder on same and has free
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
43
CDC Has Flier for Hospitals on Insulin Pens
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VA Alert on Insulin Pens
Pharmacist found several insulin pens not
labeled for individual use
Found used multi-dose pen injectors used on
multiple patients instead of one patient use
New requirement that can only be stored in
pharmacy and never ward stocked
Instituted new education for staff on use
Part of annual competency of staff
Instituted new policy of safe use of pen
injectors
45
VA Issues Alert
46
VA Alert on Insulin Pens
Decided to prohibit multi-dose insulin pen
injectors on all patient units except the
following:
 Patients being educated prior to discharge to use a
insulin pen injector
 Eligible patient is self medication program
 Patient needing treatment and no alternative
formulation is available
 Patients participating in a research protocol requiring
an insulin pen
 Pen injectors dispensed directly to patients as an
outpatient prescription
47
FDA Issues An Alert in 2009
48
Insulin Pen Posters and Brochures Available
www.oneandonlycampaign.org
/content/insulin-pen-safety
49
50
Pt Safety Briefs Free at www.empsf.org
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CMS Memo May 30, 2014
CMS publishes 4 page memo on infection
control breaches and when they warrant
referral to the public health authorities
This includes a finding by the state agency
(SA), like the Department of Health, or an
accreditation organization
 TJC, DNV Healthcare, CIHQ, or AOA HFAP
CMS has a list and any breaches should be
referred
Referral is to the state authority such as the
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state epidemiologist or State HAI Prevention
Infection Control Breaches
53
CMS Memo Infection Control
Breaches
Memo says Medicare regulations require
hospitals that accept M/M to follow their
infection control standards
Some types of infection control breaches,
such as ones related to medication
administration, pose a risk of bloodborne
pathogen transmission that warrant public
health authorities to conduct a risk
assessment
 And if necessary to contact the patient
Outside the scope of CMS but within
54
CMS Memo Infection Control
Breaches
If any of the listed breaches are observed,
then will take appropriate enforcement action
And will make the public health authority
aware
 Includes LTC, ASCs, hospice, hospitals, home
health agencies, CAH, rural health clinics and
dialysis facilities
 CDC is working closely with SA on HAI
prevention
List of breaches to be referred include:
Using the same needle for more than one55
CMS Memo Infection Control
Breaches
Using the same (prefilled/manufactured/insulin or any other)
syringe, pen or injection device for more than
one individual
Re-using a needle or syringe which has
already been used to administer medication
to an individual to subsequently enter a
medication container (e.g., vial, bag), and
then using contents from that medication
container for another individual
Using the same lancing/fingerstick device 56for
Luer Misconnections Memo
 CMS issues memo March 8, 2013
 This has been a patient safety issues for many
years
 Staff can connect two things together that do
not belong together because the ends match
 For example, a patient had the blood pressure
cuff connected to the IV and died of an air
embolism
 Luer connections easily link many medical
components, accessories and delivery devices
57
Luer Misconnections Memo
58
PA Patient Safety Authority Article
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June 2010 Pa Patient Safety Authority
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ISMP Tubing Misconnections
www.ismp.org
61
TJC Sentinel Event Alert #36
www,jointcommission.org
http://www.jointcommission.org/sentine
l_event_alert_issue_36_tubing_misco
nnections—
a_persistent_and_potentially_deadly_
occurrence/
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CMS Hospital Worksheets Third Revision
 October 14, 2011 CMS issues a 137 page memo in the
survey and certification section
 It was pilot tested in hospitals in 11 states and on May
18, 2012 CMS published a second revised edition
 Piloted test each of the 3 in every state over summer 2012
 November 9, 2012 CMS issued the third revised
worksheet which is now 88 pages
 Memo discusses surveyor worksheets for
hospitals by CMS during a hospital survey
 Addresses discharge planning, infection control,
and QAPI (performance improvement)
63
CMS Hospital Worksheets
 This is the third and final pilot and in 2014 will be
revised and Discharge Planning one is done
 Will use whenever a validation survey or
certification survey is done at a hospital by CMS for
PPS hospitals
 Not currently being used for CAH
However, highly suggest that every CAH
review and be aware of what is in these three
forms
 Helps to understand how the guidelines are
interpreted
64
Third Revised Worksheets
www.cms.gov/SurveyCertificationGe
nInfo/PMSR/list.asp#TopOfPage
65
66
CMS Hospital CoPs
Appendix W, Tag C-0150 to C 0408,
See visitation memo adding tag 10001002 which is after tag 298
It is out of order
Interpretive guidelines updated more
frequently now
Manual includes swing beds in CAHs,
67
CMS Hospital CoPs
Consider doing a gap analysis,
Take each section and on left hand side of
page document how you comply with each
section,
Time consuming but will have with compliance,
Include policies and yellow section that
corresponds to the required P&P in the CoP
Have one person in charge who can keep up with
changes and who knows what to do if CMS shows
up for validation or complaint survey
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Rehab or Behavioral Health Dept CAH
Remember, CAH can have up to a ten
bed rehab or psych (behavioral health)
unit
If so it is surveyed under the regular
hospital CoP program even though
CAH has a separate manual
It is Appendix A
Last updated June 6, 2014 and
manuals changing frequently so always
check the CMS website
69
CMS Hospital CoP Manual
www.cms.hhs.gov/ma
nuals/downloads/som1
07_Appendixtoc.pdf
70
TJC Revised Requirements
TJC or the Joint Commission (not called
JCAHO anymore) has made many changes
to bring their standards into closer alignment
with CMS
Having less differences is helpful to
hospitals,
Have some that are for hospitals that use
them to get deemed status (DS) or payment
for M/M patients,
 Will specify DS after the standard
71
Condition Level Requirement Noncompliance
72
Deficiency
Condition level- (NOT GOOD) due to
noncompliance with requirement in a single
standard or several standards within the
condition or single tag but represents a
severe or critical health breach, (need to have
conversation)
Standard level- noncompliance as above
but not of such a character to limit facility’s
capacity to furnish adequate care- no
jeopardy or adverse effect to health or safety
of patient,
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Introduction
 Medicare CoPs are found at 42 CFR Part
485 Subpart F.
Authority to make copies of things is at 42
CFR 489.53,
 Recommend you have surveyor make you a
copy also,
 Please ask surveyor not to make copy of peer
review material -abstract out what is needed,

Can get all CFR now electronically off Internet free at GPO access at
www.gpoaccess.gov

Click on Code of Federal Regulations and can do search or click on e-CFR, or
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl,
74
Resources to Keep Handy
Appendix W Hospital CoPs (“C”)
Unless CAH has a separate rehab or behavioral health unit
and then you need Appendix A- Hospital CoP also for these
departments
Survey protocol and module,
Q- Immediate jeopardy.
V-EMTALA,
W-Hospital swing beds-if you have these,
B- Home health
I-Life safety code
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Survey Procedure
The interpretive guidelines provide instructions to
the surveyors on how to survey the CoPs-like
questions to the test,
They have survey procedure instructions to
determine the hospital policy for notifying patients
of their rights,
Ask patients to tell you if the hospital told them
about their rights,
Deficiency citation show how the entity failed to
comply with regulatory requirements and not the
guidelines!
76
Survey Protocol
First 26 pages list the survey protocol,
Includes a section on:
Off-survey preparation,
Entrance activities,
Information gathering/investigation,
Preliminary decision making and
analysis of finding,
Exit conference,
Post survey activities,
77
Swing Bed Module
When patients need brief transitional care at the
hospital at the end of their acute care stay,
If swing beds then do survey under CAH swingbed requirements found at 42 CFR Part
485.645,
Reimbursement is for Skilled Nursing care as
opposed to Acute Care,
 Term is for reimbursement and has no
relationship to geographic location in the
hospital,
.
78
Swing Bed Module
May be in acute care status one day
and then in swing bed status the next
day,
3-day qualifying stay for the same spell
of illness in any hospital or CAH is
required prior to admission to swingbed status,
Actual swing-bed survey requirements
are referenced in the Medicare Nursing
Homes requirements at 42 CFR Pt 483
79
Swing Bed Counts
 Surveyor will verify 25 bed rule,
 Will count inpatient beds but not observation beds,
 Does not count OR, PACU, L&D, newborn nursery
or ED stretchers, exam tables, or observation beds
(210),
 Do count birthing beds where patients remain after
giving birth,
 Do not count beds in Medicare certified rehab or
psychiatric distinct part units,
 Will conduct open record review on all swing bed
patients,
 Swing bed deficiencies are documented on a
separate form even though survey done
simultaneously,
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Regulation/Interpretive Guidelines
Starts with a tag number, example C-0150,
C refers to the CAH CoPs,
Recall first is the section from federal
register (CFR)
Then the section called the “interpretive
guidelines”,
Some have a section called “Survey
Procedure” and will explain how it is surveyed
or what policies will be reviewed, what
questions to ask or documents to look at,
81
Compliance with Laws C-150
Standard: The CAH must be in
compliance with all federal, state, and
local laws,
Surveyor may interview CEO or other
designated by hospital to determine this,
May refer non-compliance to proper agency
with jurisdiction such as OSHA
 TB, blood borne pathogen, universal
precautions, or EPA (haz mat or waste
issues),
82
Advance Directives 151 2013
Standard: CAH must be in compliance with
federal laws and regulations related to the
health and safety of patients
Inpatients and outpatients have the right to
make advance directives
Staff must comply with their advance
directives
Patients have the right to refuse treatment
May have a DPOA or another person such
as a support person/patient advocate
83
Advance Directives 151
May use advance directives to designate a
support person for a person of exercising the
visitation rights
If patient incapacitated and DPOA then must
give this information to make informed
decisions and consent for the patient
CAH must also seek the consent of the
patient’s representative when informed
consent is required for a care decision
 Surrogate decision makers step into the shoes of
patient when incompetent
84
Advance Directives 151
Must provide advance directive information
to the competent patient when admitted
 Must also give to the outpatient if in the ED,
observation, or same day surgery patient
 Must document you gave it in the medical
record
If incapacitated then give to the family or
surrogate
Has conscience objector clause but must still
allow DPOA or support person to make
decision if incapacitated
85
Advance Directives 151
Can not require one
Document in the medical record
Must make sure staff is educated on the
P&P
This includes the right to make a psychiatric
advance directive or mental health
declaration
 Should still give consideration even if not a
state specific law
Must provide community education
86
Physician Ownership Disclosures 151
Must disclose if physician owned hospital
 This includes ownership by immediate family member and
must be in writing
 If none of physician owner refer then the hospital must sign
attestation to this effect
 Physicians must also disclose to patients who
they refer
 This must be as a condition for getting MS
privileges
 Disclose in writing if physician not on premise 24
hours a day for emergencies
 Sign acknowledgement if patient admitted
87
Compliance with Laws/Licensure
Standard: Patient care services must be
provided with in accordance with laws (152),
Ensure delegation as allowed by law,
Ensure practicing according to scope of
practice, such as NP, CNS, PA,
Standard: Hospital must be licensed (153)
Personnel must be licensed or certified if
required by state (Tag 154: doctors, nurses, PT,
PA, OT, x-ray tech. et. al.),
Review sample of personnel files to be
credentials and licensure is up to date,
88
Status/Location 160
If CAH moves then status and location
must be reassessed
 Harder to relocate now, See tag 166 on
relocation
Many changes to relocation and allows
for grandfathering (see SOM Manual 2)
Criteria for determining mountainous
terrain, revised definitions of primary
and secondary roads, documentation
needed to relocate CAH and 75% rule,
89
Status and Location
160-162 2013
CAH must meet the location requirements at
the time of the initial survey (160)
Compliance is reconfirmed at the time of
every subsequent full survey
Tag 162 discusses information regarding if
the CAH has been classified as an urban
hospital
Discusses CAH located outside any area that
is a metropolitan statistical area
CAH must be in a rural area
90
Q&A
91
Location in a Rural Area 8-30-13
92
Agreement with Network Hospitals 191
Standard: CAH that is a member of a rural
network must have agreement with at least
one hospital that is a member of the
network
A CAH must develop agreements with an
acute care hospital related to patient
referral and transfer, communication,
emergency and non-emergency patient
transportation
Will ask how CAH communicates with other
hospitals- do you keep a communication log?
93
Working with the Other Hospital
What P&P related to communication
system?
Will review any written agreements with
local EMS
Need to provide for transport between
the two facilities
Do the two hospitals have electronic
sharing of patient data, telemetry and
medical records? (193)
94
Credentialing and QA Agreement 195
Standard: The CAH has to have an
agreement with a hospital that is a member
of the network or QIO for quality
improvement and credentialing
 State networking requirements vary.
 Agreement for QA need to include a medical
record review as part of quality and to establish
medical necessity of care at CAH,
 Surveyor will review P&P to determine how
information is obtained, used and how
confidentiality is maintained,
95
Telemedicine Agreements C&P 196
Standard: Agreements for C&P Telemedicine
Physicians
 Board must make sure agreement with distantsite hospital (DSH) or distant-site telemedicine
entity (DSTE)
 Decide what category of practitioners are eligible
for appointment to the MS
 Board appoints with recommendation of the MS
 Board approves the MS bylaws and other MS
rules and regulations
96
Telemedicine December 22, 2011
97
Agreements for C&P 196
Make sure MS is accountable to the board
for quality of care provided to the patients
Must have and follow criteria for selection of
MS that is based on individual character,
competence, training, experience, and
judgment
Make sure under no circumstance is
privileges based solely on certification,
fellowship, or membership in a special body
or society
98
Telemedicine C&P
197
99
Emergency Services 200
Standard: Must provide emergency care
necessary to meet the needs of its inpatients
and outpatients,
The ED cannot be a provider-based off-site
location,
Must comply with acceptable standards of
practice,
Including those established by national
professional organizations such as ACEP, ENA,
ACS, ANA, AMA, American Association for
Respiratory Care,
100
Emergency Services
Need qualified medical director,
MS must have P&P regarding the care
provided in the ED,
Policies current and revised based on
QA activities,
MS must establish qualifications to get
privileges to provide ED care,
ED must be adequately staffed,
Must have adequate equipment,
101
Emergency Services 200
Must determine the categories and
numbers of staff needed in the ED
 MD/DO, RN, ward clerks, PA, NP, EMTs,
The scope of diagnostic and/or
therapeutic respiratory services offered
by the CAH should be defined in
writing, and approved by the medical
staff
 CT scans, venous Doppler's, ultrasound et. al.,
102
14 ED Written Policies
P&P must be developed approved by
MS,
And mid-level practitioners who work in
the ED,
Need triage procedures,
Each type of service provided,
Qualifications, education, training, of
personnel authorized to perform
respiratory care services and if
supervision is needed,
103
ED Written Policies
• Equipment assembly and operation;
• Safety practices, including infection control
measures;
• Handling, storage, and dispensing of
therapeutic gases;
• Cardiopulmonary resuscitation;
• Procedures to follow in the event of adverse
reactions to treatments or interventions;
• Pulmonary function testing;
104
ED Written Policies
• Therapeutic percussion and vibration;
• Bronchopulmonary drainage;
• Mechanical ventilatory and oxygenation
support;
• Aerosol, humidification, and therapeutic
gas administration;
• Administration of medications; and
• Procedures for obtaining and analyzing
ABGs.
105
ED Staff Training
Surveyor will interview ED staff to make sure
knowledgeable including (so include in
education of ED staff):
1. Parenteral administration of electrolytes,
fluids, blood and blood components;
2. Care and management of injuries to
extremities and central nervous system;
3. Prevention of contamination and cross
infection; and
4. Provision of emergency respiratory
services.
106
EMTALA and ED 24 hours
Must still meet EMTALA (anti-dumping)
requirements,
Revised July 16, 2010 into 68 pages,
Must have 24 hour ED services available,
A CAH without inpatients is not required to
have emergency staff on site 24 hours a day
(If no patients, CAH may close),
Can have NP, PA, or MD on site within 30
minutes,
107
EMTALA, CAH & Telemedicine Memo
CMS welcomes the use of telemedicine by
CAH
CAH not required to have a doctor to
appear when patient comes to the ED
PA, NP, CNS, or physician with
emergency care experience must show up
within 30 minutes
If MD/DO does not show up must be
immediately available by phone or radio
contact 24 hours a day
108
CMS S&C Memo EMTALA & CAH
109
Availability of Drugs 201
CAH must maintain the types, quality and
numbers of supplies, drugs and
biologicals, blood and blood products,
and equipment,
Required by state and local law and in
accordance with accepted standards of
practice,
Surveyor will ask how you make sure
equipment, supplies, and medications are
always available,
110
Emergency Drugs 203
Drugs used in life-saving procedures,
includes;
Analgesics, local anesthetics, antibiotics,
anticonvulsants, antidotes and emetics,
serums and toxoids, antiarrythmics, cardiac
glycosides, antihypertensive, diuretics, and
electrolytes and replacement solutions.
Know how you maintain your inventory
and how drugs are replaced,
111
Emergency Equipment 204
Equipment and supplies commonly
used in life-saving procedures,
includes;
 Airways, endotracheal tubes, ambu
bag/valve/mask, oxygen, tourniquets,
immobilization devices, nasogastric tubes,
splints, IV therapy supplies, suction machine,
defibrillator, cardiac monitor, chest tubes, and
indwelling urinary catheters.
112
Emergency Equipment 204
Make sure staff know where the
equipment is located,
Know how supplies are replaced and
who is responsible for doing this,
Will examine sterilized equipment for
expiration dates,
Will check for equipment maintenance
schedule (defibrillator),
113
Blood and Blood Products 205
Need services for the procurement,
safekeeping, and transfusion of blood,
including the availability of blood
products needed for emergencies on a
24-hours a day basis ,
No requirement to store blood on site,
Can provide in emergency directly or through
arrangement,
Some cases more practical to transport
patient to where the blood is,
114
Blood and Blood Products
If CAH does tests on blood will be surveyed
under CLIA if tests are done,
If collecting blood you must register with the
FDA,
If only storing blood for transfusion and
refers all tests to outside lab then not
performing test as defined by CLIA,
Need agreement in writing regarding the
provision of blood between CAH and testing
lab,
115
Blood and Blood Products
Blood must be appropriately stored to
prevent deterioration,
If types and cross matches must have
necessary equipment
Or can keep 4 units O Neg on hand at
all times,
Release to give, signed by doctor, is
needed if not cross matched when
indicated in an emergency
116
Blood Storage 206
Blood storage must be under the
control and supervision of a
pathologist or other qualified doctor,
If blood banking done under
arrangement, the arrangement has
to be approved by MS and
administration,
Will look for an agreement,
117
Staffing Personnel 207
Must have practitioner (physician, PA,
NP) with training in emergency care on
call and immediately available within 30
minutes,
60 minutes if CAH in frontier area (with less than 6
residents per sq. mile and area meets criteria for
remote by the state and CMS) and state
determines longer time than 30 minutes needed is
only way to provide care,
Will review call schedules,
Will ask staff if they know who is on call,
118
Staffing Personnel 207
 Will review documentation that PA, NP, or MD was
on site within this time frame,
 RN will satisfy this if for temporary period and CAH
has less than 10 beds and is in frontier area (state
governor has to sent letter to CMS as part of rural
health plan),
 CAH must submit this letter to surveyor and
demonstrate shortage and unable to provide,
 Also if state law has more stringent staffing
requirements, like MD on duty 24 hours, must
follow,
 See CMS Memo
119
Coordination with EMS 209
 Must coordinate with EMS,
 Have a procedure where available by
phone or radio on 24 hour basis to
receive calls,
 Should have policies and procedure in
place to ensure MD/DO is available by
phone or radio contact,
 And when emergency instructions are
needed,
120
25 Available Beds 211
CAH maintains no more than 25 acute
care beds at any one time
 Doesn’t include observation beds
Any of the 25 beds can be used to provide
acute or long term care (swing beds)
dependent on patient need
Does not count if CAH has up to 10 bed
rehab unit or behavioral health unit
Average basis of 96 hours per patient,
121
Observations/LOS 211
Previously, could not operate distinct units,
Observations stay is usually not more than 48
hours, unless more strict state limit of 24 hours,
Rewrite your policy on observation beds to meet
this section and the 2 midnight rule,
They do not count observation beds in 25 bed
count now or in calculating average LOS,
Make sure you are using appropriately,
See the CMS memo on the two midnight rule
 Place in an outpatient observation bed
 Admit as an inpatient to telemetry
122
123
Two Midnight Rule
 Need an order and need to document medical
necessity
 For inpatient CAH services only, the physician must
certify that the beneficiary may reasonably be
expected to be discharged or transferred to a
hospital within 96 hours after admission to the
CAH.
 Time as an outpatient at the CAH does not count
towards the 96 hours requirement.
 The clock for the 96 hours only begins once the individual is
admitted to the CAH as an inpatient.
 Time in a CAH swing-bed also does not count towards the 96 hour
inpatient limit.
124
Observations 211
Inappropriate use of observation beds
subjects Medicare beneficiary to increased
coinsurance liability
 20% of CAH customary charges then if properly
admitted as inpatient,
Observation is not appropriate for :
 Substitute for inpatient admission
 For continuous monitoring
 Medically stable patients who need
diagnostic testing or outpatient procedure
(blood chemo, dialysis)
125
Observation Not Appropriate
Patients awaiting nursing home placement
For convenience to the patient or family
For routine prep or recovery prior to or after
diagnostic or surgical services
As a routine stop between the ED and
inpatient admission
No prescheduled observations services
Observation services begin and end with the
order of the physician
126
Observation 211
Must provide documentation to show that
observation bed is not an inpatient bed
Need specific criteria for observation
services
Must be different than inpatient criteria
10 bed observation unit might be
disproportionately large
Surveyor might determine observation is
actually inpatient overflow unit
127
Don’t Count in 25 Bed Count 211
Exam or procedure tables
Stretchers
OR tables and PACU bed
Newborn bassinets and isolettes for well
baby boarders
OB beds if active labor but do count birthing
rooms where patient stays after giving birth
ED carts
 10 bed distinct unit rehab or behavioral health
128
Beds/ LOS Hospice 211
Observation starts and ends with order
 No standing orders for observation
Hospice beds can be dedicated are also
counted as part of the 25 beds,
Except 96 hour average LOS rule does not
apply,
Medicare does not reimburse the CAH for
hospice patients only the Hospice,
So the CAH has to negotiate payment from
the hospice through an agreement,
129
Length of Stay 212
That does not exceed, on an annual
average basis, 96 hours per patient,
State Fiscal Intermediary (FI) will
determine compliance with this CoP,
 Calculate the CAH’S length of stay based
on patient census data,
 If CAH exceeds the length of stay limit,
the FI will send a report to the CMS-RO
as well as a copy of the report to the SA,
CAH will have to do plan of correction,
130
Construction 6-7-2013
Standard: CAH is constructed, arranged, and
maintained to ensure access to and safety
of patients
Additionally, it must provide adequate space
to provide care to patients
Must be constructed in accordance with state
and federal law
Will look to see if maintained in a manner to
ensure safety of patients
 Conditions of ceilings, walls, and floors
131
Physical Environment 222
Must have housekeeping and preventative
maintenance programs,
All essential mechanical, electrical, and patient-care
equipment is maintained in safe operating condition
These means facilities, supplies and equipment
must be maintained,
How do you ensure your equipment is maintained
properly
 Boilers, elevators, air compressors, ventilators,
X-ray equipment, IV pumps, stretchers, IV
equipment, air compressors, elevators, maintenance log,
132
CMS Hospital Equipment Maintenance
133
Physical Environment
Dept responsible for building and dept must be
incorporated into hospital QA process.
Applies to all campuses, satellites, inpatient and
outpatient locations,
Is there adequate space for providing direct patient
care?,
Will tour to make sure space to ensure patient
safety,
Will look at housekeeping and preventive
maintenance (PM) programs,
Evaluate to be sure trash is disposed of properly
and promptly,
134
Disposal of Trash
223
Standard: There is proper routine
storage and prompt disposal of trash,
Includes biohazardous waste,
Must be disposed of in accordance with
standards (EPA, OSHA, CDC, environmental
and safety),
Includes radioactive materials,
Will look for policies for proper storage and
disposal,
135
Storage of Drugs 224
Standard: Drugs and biologicals must
be appropriately stored,
Must be properly locked in the storage area,
 Make sure medication carts in C-section rooms
are locked
 Make sure drugs are not left out in open in tube
system or on dumb waiter ledge
Surveyor will ask what standards,
guidelines, or law you using to make
sure they are stored,
136
Physical Environment 225
 Standard: Premises clean and orderly
 Means uncluttered with equipment not
stored in corridors,
 Area is neat and well kept
 Spills not left unattended,
 No peeling paint or floor obstructions,
 No visible water leaks or plumbing
problems
137
Proper Ventilation 226 1-31-14
 Standard; There must be proper ventilation,
lighting, and temperature controls,
 In pharmaceutical, patient care and food
preparations
 Proper ventilation in areas with nitrous
oxide, glutaraldehyde, xylene, pentamidine,
or other potentially hazardous substances,
 Isolation rooms comply with laws such
CDC 2007 Isolation Guidelines, OSHA,
NIH, et al,
138
Physical Environment 226
 Temperature, humidity and airflow in the operating
rooms must be maintained within acceptable
standards to inhibit bacterial growth and prevent
infection,
 Including anesthetizing locations where inhalation
anesthesia agents are used
 Excessive humidity in the operating room is
conducive to bacterial growth and compromises the
integrity of wrapped sterile instruments and supplies,
 RH at 35% or greater unless waiver is used of 20% or
greater
 Acceptable standards such as from AORN or the
Facilities Guideline Institute or FGI) should be
incorporated into CAH policy.
139
CMS Memo April 19, 2013
 CMS issues memo related to the relative
humidity (RH)
 AORN use to say temperature maintained
between 68-73 degrees and humidity between
30-60% in OR, PACU, cath lab, endoscopy
rooms and instrument processing areas
 CMS says if no state law can write policy or
procedure or process to implement the waiver
 Waiver allows RH between 20-60%
 In anesthetizing locations- see definition in memo
140
Humidity in Anesthetizing Areas
141
Proper Ventilation & Lighting 1-31-14
142
CMS Memo April 19, 2013
CMS issues memo related to the relative
humidity (RH)
AORN use to say temperature maintained
between 68-73 degrees and humidity
between 30-60% in OR, PACU, cath lab,
endoscopy rooms and instrument processing
areas
CMS says if no state law can write policy or
procedure or process to implement the
waiver
143
Waiver allows RH between 20-60%
Physical Environment 226
Must have adequate number of
refrigerators to make sure foods and meds
are stored,
Surveyor will verify these areas are well lit,
Surveyor will verify compliance with
ventilation in patients with TB or other
airborne diseases,
Surveyor will verify food products are
stored under appropriate conditions (time,
temperature, packaging) based on national
sources like USDA and FDA,
144
Emergency Procedures 227
Standard: Assure safety of patients
in non-medical emergencies,
Staff trained in handling
emergencies such as reporting and
extinguishing of fires, evacuations,
et al.,
Report all fires to the state officials,
Will interview staff to make sure
they know what to do in case of a
fire,
145
Physical Environment 227
How do you ensure all personnel are
trained to manage non medical
emergencies?
Ask staff what to do in case of a
tornado, hurricane, earthquake, or
blizzard,
Review staff training documents and
in-service records to confirm training,
146
Physical Environment 228
Standard: Provide for emergency power
and lighting in ED and for battery lamps
or flashlights in other areas,
Must comply with the applicable provisions of
the Life Safety Code,
National Fire Protection Amendments
(NFPA) 101, 2000 Edition and applicable
references such as NFPA-99: Health Care
Facilities, for emergency lighting and
emergency power,
147
Emergency Fuel and Water 229
Standard: Provide for emergency fuel and
water supply (snow bound or flooding),
 Must have system to provide emergency gas and
water as needed to provide care to inpatients and
other persons who may come to the CAH in need
of care,
Includes making arrangements with local
utility companies and others for the provision
of emergency sources of water and gas,
 Source of information on water is FEMA,
 Have a plan for prioritizing their use until adequate
supplies are available,
148
Emergency Preparedness Plan 230
Develop a comprehensive plan to ensure
that the safety and well being of patients are
assured during emergency situations,
 Coordinate with Federal, State, and local
emergency preparedness and health authorities to
identify likely risks for their area (e.g., natural
disasters, bioterrorism threats, disruption of utilities
such as water, sewer, electrical communications,
fuel; nuclear accidents, industrial accidents, and
other likely mass casualties, etc.)
 Develop appropriate responses that will ensure the
safety and well being of patients.
149
CMS Revised Checklist Memo
CMS issues 8 page memo on Feb 28, 2014
Regarding checklist for emergency
preparedness (EP)
Update provides information about patient
tracking, supplies and collaboration
Discusses Oct 24, 2007 memo on EP
 This updated checklist can be found at S&C
Emergency Preparedness Website
http://www.cms.hhs.gov/SurveyCertEmergPr
ep
150
CMS Revised Checklist
151
152
Proposed Changes EP Requirements
CMS publishes proposed rule in the Federal
Register on December 27, 2013
Requires hospitals that accepts Medicare or
Medicaid to adequately plan for disasters
Whether natural or man made
Would have to coordinate with federal, state,
and local emergency preparedness systems
To enhance patient safety during an
emergency
153
Proposed Changes EP Requirements
154
Emergency Preparedness Plan
The following issues should be considered
when developing the comprehensive
emergency plans:
 Differences needed for each location where
the certified CAH operates;
 Special needs of patient populations treated
at the CAH (e.g., patients with psychiatric
diagnosis, patients on special diets, newborns,
etc.);
 Security of patients and walk-in patients;
 Security of supplies from misappropriation;
155
Emergency Preparedness Plan
Pharmaceuticals, food, other supplies and
equipment that may be needed during
emergency/disaster situations;
Communication to external entities if
telephones and computers are not
operating or become overloaded (e.g., ham
radio operators, community officials, other
healthcare facilities if transfer of patients is
necessary, etc.);
Communication among staff within the CAH
itself;
156
Emergency Preparedness Plan
 Qualifications and training needed by
personnel, including healthcare staff, security
staff, and maintenance staff, to implement and
carry out emergency procedures;
 Identification, availability and notification of
personnel that are needed to implement and
carry out the CAH’S emergency plans;
 Identification of community resources,
including lines of communication and names
and contact information for community
emergency preparedness coordinators and
responders;
157
Emergency Preparedness Plan
Provisions for gas, water, electricity
supply if access is shut off to the
community;
Transfer or discharge of patients to
home or other healthcare settings,
Methods to evaluate repairs needed
and to secure various likely materials
and supplies to effectuate repairs.
158
FIRE Inspections 231-233
Must meet LSC of National Fire Protection
Association such as NFPA-99 (231)
CMS can allow state surveyor to apply
state’s fire and safety code if CMS finds that
it adequately protects patients
CMS can waive specific provisions of the
LSC if it would result in unreasonable
hardship
 But only if the waiver does not put patients at
risk
159
FIRE Inspections
234
Maintains written evidence of
regular inspection and
approval by State or local fire
control agencies,
Surveyor will examine copies
of inspection and approval
reports from State and local
fire control agencies,
160
Governing Body 241
Standard; CAH has a governing body or
individual that assumes legal responsibility
for implementing and monitoring P&Ps,
Must have 1 governing body or responsible
person,
Board must determine what categories of
practitioners are eligible for appointment and
reappoint to MS (NP, PA, dentist, CRNA) and
there is written criteria for staff appointments,
Done with advice of MS,
161
Governing Body 241
Must be consistent with state and federal law
requirements,
Board approves MS bylaws and any
revisions
 Surveyor will look for this,
Board responsible for conduct of CAH and
for quality of care to patients,
All patients must be under the care of a
member of the MS
 Or under care of member of MS under their
supervision
162
Governing Body
 Criteria for MS is based on individual
character, competence, training,
experience and judgment,
 Surveyor will look to see Board or written
documentation of person responsible for
CAH,
 Will look to verify that Board has categories
of practitioners for appointment to MS,
 Confirm that Board appoints all members
to the MS,
163
Disclosure
242
CAH discloses the names and addresses of
its owners or those with controlling interest,
Either directly or indirectly has 5% or more
ownership,
Surveyor will look for policy on reporting
changes of ownership,
Need policy on how to reporting changes for
person responsible for operation of hospital
(CEO) to state agency and also for reporting
changes in medical director (243,244),
164
Staffing 250
Standard: CAH has professional staff
that includes one or more physicians,
and may include PA, NP, or CNS,
Need to have organizational chart
which shows names of all MD/DO and
mid-level providers
 PA, NP, or CNS
Surveyor will review work schedules,
165
Staffing 252
Standard: All ancillary staff must be
supervised by professional staff,
Have sufficient staff to take care of
patients
 Emergency services, nursing services, Tag 253,
Will review staffing schedules and daily
census records,
 Make sure answer call lights promptly
 Make sure address monitor that alarms timely
166
Staffing 254
MD, DO, NP, PA, or CNS must be
available at all times to furnish care,
Must show practitioner is available
and shows up when patient presents
to the hospital,
Doesn’t mean they have to be there
24 hours a day,
167
Nurse on Duty 255
Standard: Must have a
RN, CNS, or LPN on
duty whenever there is
one or more inpatients,
Surveyor will review
staff schedules to make
sure,
168
Physician Responsibilities 257
Standard: MD/DO must provide medical
directions and supervision of staff,
Surveyor will make sure is available for
consultation and supervision of staff,
Physicians must periodically review charts
of PA and NP and surveyor will look for
documentation of same (259),
MD/DO must provide orders for patients and
must review and sign all MR cared by PA,
NP, or CNS (260),
169
Physician Supervision
Must have a doctor on staff and must
perform medical oversight,
 Must be present for sufficient period of
times or at least once every two week to
provide direction (changed July 11, 2014)
Will want evidence that the Dr. provides
oversight and is available for consultation or
patient referral,
What evidence the there is periodic review of
patient records by the doctor?
170
PA, NP, CNS 263
Must be members of CAH staff,
Must participate in development and review
of P&P,
Interview them to determine their
participation and knowledge of policies,
Will interview to determine their level of
involvement in development of P&Ps and
make updated,
Policies also need to be consistent with
state standards of practice,
171
Transfer of Patients 267
Standard: Arrange for transfer of
patients who need services that
can not be furnished,
 Must sent the patient’s medical
records,
 Remember EMTALA is a separate
CoP that every CAH must follow,
 Make sure you have a transfer policy
and it should be consistent with
EMTALA,
172
Patient Admission 268
 Standard: Whenever a patient is admitted by
NP, PA, or CNS, a physician on the staff must
be notified,
 CMS requires that Medicare and Medicaid patients
be under the care of a MD/DO if patient has
medical or psych problems that are outside of the
scope of their practice,
 Admitting privileges must be consistent with what
state law allows,
 Surveyor will look to make sure MD/DO monitor
care for any medical problem outside their scope of
practice,
173
Patient Care Policies 271
Standard: Services are provided in
accordance with appropriate P&P,
Will review policies,
Review sampled records,
Observe staff delivering care to the patient,
P&P need to be developed by group of professional
person sand include 1 MD/DO and 1 or more PA,
NP, CNS if on staff and removed requirement for
one member is who not a member of the staff (272),
Will interview CNO to determine role in policy
development (272),
174
Policies (Scope of Services) 273 2013
Standard: Need P&P on scope of services
provided by CAH directly or through
agreement,
 Should include statements like “taking complete
medical histories, providing complete physical
examinations, laboratory tests including” (with a
list of tests provided) would satisfy this
requirement,
 Should include arrangements made with Hospital
X for providing the following services with list of
specialized diagnostic and lab testing,
175
Emergency Medical Services 274
Need P&P for emergency medical
services,
Policies should show how the CAH
would meet all of its emergency
services requirements,
176
Guideline for Medical Management 275
Guidelines on managing health
problems that include when medical
consultation is needed,
And patient referral (275),
Guidelines on maintaining medical
records and procedure for periodic
review and evaluation of the services
provided at the CAH,
177
Medical Management 275
Needs to include the scope of medical
acts which may be done by PA or NP,
What medical procedures can PA or
NP do?
Guidelines need to describe the
medical conditions, signs or
development that require consultation,
178
The End! Questions??
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
sdill1@columbus.rr.com
179
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